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Logo TETAGAM IM 250 IU solution for intramuscular injection
TETAGAM IM 500 IU solution for intramuscular injection

REGISTRATION NUMBER
Tetagam IM
250 IU: T/30.2/743
Tetagam IM 500 IU: T/30.2/744

PROPRIETARY NAME
(and dosage form):

TETAGAM IM 250 IU solution for intramuscular injection
TETAGAM IM 500 IU solution for intramuscular injection

DESCRIPTIVE NAME OF THE MEDICINE
Human
tetanus immunoglobulin

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Tetagam IM
contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to tetanus toxin.
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Tetagam IM is prepared by cold ethanol fractionation to further reduce the risk of viral transmission.
Each ampoule Tetagam IM 250 IU contains 250 IU (125 IU/mL) tetanus antibodies.
Each ampoule Tetagam IM 500 IU contains 500 IU (500 IU/mL) tetanus antibodies.
This preparation contains no antimicrobial preservative and is stabilised with glycine.

IDENTIFICATION
A clear, pale yellow or light brown liquid exhibiting slight opalescence.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Tetanus immunoglobulin confers passive immunity against tetanus.

INDICATIONS
Prophylaxis in patients with wounds contaminated by Clostridium tetani in conjunction with appropriate wound management and simultaneous active immunisation using a different injection site and syringe.

IMMUNE STATUS
CLEAN MINOR WOUNDS
(Tetanus Infection Unlikely)
CLEAN MINOR WOUNDS
(Tetanus Infection Unlikely)
ALL OTHER WOUNDS (Dirty Wounds) ALL OTHER WOUNDS (Dirty Wounds)
  Tetanus immunoglobulin Tetanus toxoid Tetanus immunoglobulin Tetanus toxoid
Unknown No Yes Yes Yes
Incomplete Course of Toxoid No Yes Yes Yes
Complete Course of Toxoid: 
Last Booster >10 years ago No Yes Yes Yes
Last Booster 5-10 years earlier No Yes No Yes
Last Booster within past 5 years No No No No
Tetagam IM supplements but does not replace antibiotic therapy.

Treatment:
Tetagam IM may be used to treat clinical tetanus both locally by infiltration into the wound site, as well as intramuscularly.

CONTRA-INDICATIONS
Intramuscular injections are not advocated for patients with bleeding disorders.
The risk-benefit ratio in patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products should be considered.
The safety of intramuscular immunoglobulin in pregnancy has not been established in controlled clinical trials.
This intramuscular preparation should not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
INDICATIONS DOSE
Prophylaxis:
High risk injuries to non-immune and immune patients
250 IU in patients 10 years and older. (500 IU if 24 hours have passed since injury or if there is a risk of heavy contamination);
Treatment:
Clinical tetanus
3000 IU - 6000 IU as a single dose

Warm the ampoule to body temperature before injecting intramuscularly.
If large doses (>5 mL) are required, it is advisable to administer them in divided doses at different sites.
Discard any unused portion.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Local reactions, with pain and tenderness may occur at the injection site. Fever, chills, flushing, lightheadedness, backache, nausea and cutaneous reactions have also been reported.
Anaphylactic reactions may occur, especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, should be immediately available when administering Tetagam IM.
Persons with selected IgA deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material.
Tetagam IM can be given along with tetanus toxoid for passive-active immunisation. Administer intramuscularly at a different site to avoid interference with active antibody response.
Infectious diseases due to the transmission of infectious agents, cannot be totally excluded. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Administration of vaccines: The effect of live vaccines (e.g. measles, mumps, rubella and varicella) may be inhibited if immunoglobulins are given. They should not be administered until three months after the administration of immunoglobulins.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
None known.

PRESENTATION
2 mL (250 IU) in a single dose, clear, colourless 2 mL glass ampoule.
1 mL (500 IU) in a single dose, clear, colourless 2 mL glass ampoule.

STORAGE DIRECTIONS
Transport within 72 hours below 37°C.
Store below 2°C and 8°C.
Do not freeze.
Protect from light.
Keep out of reach of children

NAME OF APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone No. (031) 719 6789         Telefax: No. (031) 708 5614

DATE OF PUBLICATION OF PACKAGE INSERT
1/96

2004/01P55

Date of Amendment: 10 July 1998         Date of Approval: 23 July 1998
Updated on this site: June 2010
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at +27 (0)31 714 6700 or +27 (0)82 870 3705 or +27 (0)82 895 0056
.

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